Navigation Links
Crucell's Rabies MAb Enters Phase I Trial in India

Dutch biotechnology company, Crucell N V’s Rabies monoclonal antibody (mAb) product has entered a phase I clinical study in India, four months after launching// a similar study in the US.

Crucell has developed a human monoclonal antibody product for the post-exposure prophylaxis of rabies, using Crucell’s MAbstract and Crucell’s PER.C6 technologies. This second phase I study is closely linked to the initial phase I study that is currently being performed in the US. Both studies are conducted under FDA authority, the Indian phase I study gained approval upon review by the Drug Controller-General of India (DCGI).

The clinical trial will be a randomized, double-blind, placebo controlled study in 44 healthy volunteers that will test the antibody product alone in a dose escalation as well as in combination with rabies vaccine. The study, funded by Crucell, will be conducted through a undisclosed clinical research organization in Mumbai, India. The main parameters under investigation will be safety, tolerability and rabies virus neutralizing activity.

“We are very pleased that would could initiate this second phase I trial, as it follows favorable interim safety and tolerability data from the initial US study. The clinical testing of the Rabies antibody cocktail in Asia is the next important step for the program, as the global burden of Rabies is mostly affecting this continent. In addition to clinical evaluation of the rabies mAb cocktail in India, we are currently exploring the conduct of clinical trials in other Asian countries, including China,” said Mr Jaap Goudsmit, Chief Scientific Officer at Crucell.

Dr Deborah Briggs, Director of the Alliance for Rabies Control opined that there is a tremendous need for additional sources of rabies immune globulins (RIG) throughout the world, especially in Asia where less than three percent of patients undergoing post-exposure prophylaxis actually receive passive immune produ cts. She said new mAb products similar to Crucell’s product will soon be available to help to solve the shortage problem and save human lives.

Source: BioSpectrumSRM
'"/>




Related medicine news :

1. Transfer Of Rabies Virus Possible From Organ Donor To Recipient
2. Rabies Requires Immediate Treatment
3. Student Bitten By Bat And Diagnosed With Rabies In Critical Condition
4. WB Asks Centre To Continue Supply Of Anti-Rabies Vaccine
5. Community Awareness Is Imperative For Eradication Of Rabies
6. Digital ID Chips Implanted in Dogs to Prevent Rabies
7. International Collaboration Takes Aim at Rabies
8. Bharat Biotech Launches Anti-Rabies Vaccine
9. WHO on an Anti Rabies and Snake Bite Mission
10. More Indians Die of Rabies Annually
11. New Vaccine to Tackle Rabies in Dogs
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:2/23/2017)... ... February 23, 2017 , ... Top cosmetic and periodontal ... program today with a new Indiegogo campaign . Individuals are now able ... in the Los Angeles area, either as a participating patient or through an Indiegogo ...
(Date:2/23/2017)... ... February 23, 2017 , ... HealthPostures, the desk for ... expert sit stand solutions representative to the Minneapolis Home and Garden Show which is ... event that is garnering national attention is the Minneapolis Convention Center. , From ...
(Date:2/23/2017)... ... February 23, 2017 , ... Carlos Gutierrez ... has also continued to spiritually evolve, which is the purpose of everyone in this ... Spiritual Truths ” (published by Balboa Press) attempts to guide readers to expand one’s ...
(Date:2/22/2017)... , ... February 22, 2017 , ... ... athletics. It’s enough to overwork even the sharpest brain. , Power On, a ... healthy activity without over clocking the brain. Each capsule contains Cognizin® Citicoline, a ...
(Date:2/22/2017)... ... February 22, 2017 , ... ... medicine in recent years. The technology is so cutting edge, in fact, the ... protocol for stem cell procedures. However, successful patient outcomes in certain clinical stem ...
Breaking Medicine News(10 mins):
(Date:2/23/2017)... DUBLIN , Feb 23, 2017 Research ... Prosthetic Devices Market Analysis & Trends - Industry Forecast to 2025" ... ... to grow at a CAGR of around 9.2% over the next ... industry report analyzes the market estimates and forecasts for all the ...
(Date:2/23/2017)... 23, 2017 MabVax Therapeutics Holdings, ... development company, announces that it has received notice ... authorizing the initiation a Phase I clinical trial ... cancer. MVT-1075 ( 177 Lu-CHX-A?-DTPA-HuMab5B1) is the Company,s ... to initiate the phase I clinical trial in ...
(Date:2/23/2017)... , Feb. 22, 2017 Orthopedic ... implant demand, as aging demographic patterns lead to ... Implants for sports- and exercise-related injuries, chronic back ... will lead sales gains. The future of medical ... addresses the following questions and more: - ...
Breaking Medicine Technology: